Guided Application of Ventricular Catheters (GAVCA)
Randomized Controlled Multi-center Trial Comparing the Ventricular Catheter Location Between Instrument Guided and Freehand Placement.
研究概览
详细说明
Free-hand placement of ventricular catheters (VC) is reported to be inaccurate in 10-40%. Furthermore, there is evidence that the quality of VC positioning is correlating with the risk for proximal shunt obstruction. Ultrasound or neuronavigation are used in order to improve to placement. However, they are associated with significant technical efforts and increased time.
In this study a simple instrument assisted by a smart phone application software is used in order to achieve precise placement of ventricular catheters. The results are compared with the standard free-hand procedure. Patients requiring a ventricular catheter are randomized to one of the two treatments. The primary outcome parameter is a qualitative and quantitative assessment of the position of the ventricular catheter on a post-operative image. The evaluation of the primary criteria is performed by a radiologist blinded to the randomization arm.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Berlin、德国、13353
- Charité University Hospital, Division of Pediatric Neurosurgery
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Berlin、德国
- Trauma Hospital Berlin, Clinic for Neurosurgery
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Düsseldorf、德国
- University Hospital Düsseldorf, Clinic for Neurosurgery
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Göttingen、德国、37075
- Univeristätsmedizin Göttingen, Neurochirurgie
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Hannover、德国、30625
- Medizinische Hochschule Hannover, Neurochirurgie
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Heidelberg、德国
- Heidelberg University Hospital, Department of Neurosurgery
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Kassel、德国
- Klinikum Kassel GmbH / Department of Neurosurgery
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Neubrandenburg、德国
- Dietrich-Bonhoeffer-Klinikum / Department of Neurosurgery
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Tübingen、德国
- University Hospital Tübingen, Department of Neurosurgery
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参与标准
资格标准
适合学习的年龄
- 孩子
- 成人
- 年长者
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Patients requiring a permanent ventricular catheter for the treatment of CSF (cerebrospinal fluid) - circulation disorder or another disease (ventricular shunt oder Ommaya/Rickham-Reservoir)
- Frontal occipital horn ratio (FOHR) < 0.5
- Use of a new puncture channel
- Frontal access to the ventricles
- Patient´s informed consent
Exclusion Criteria:
- Known unevenness of the skull at the entry point
- Slit ventricles; Frontal and occipital horn width ratio (FOHWR) < 0.05
- Participation in another clinical trial with interfering endpoints
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Thomale-Guide
Positioning of ventricular catheter with the Thomale-Guide instrument
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Ventricular catheter placement with the Thomale-Guide instrument
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其他：Free-hand
Ventricular catheter placement without a guidance (free-hand)
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Ventricular catheter placement without a guidance (free-hand)
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
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Rate of he primary successful ventricular catheter placement with a Grade I or Grade I b and location in the ipsilateral ventricle
大体时间：Within the first 40 days
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Within the first 40 days
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合作者和调查者
赞助
调查人员
- 首席研究员：Ulrich W Thomale, PD Dr. med.、Charite University, Berlin, Germany
出版物和有用的链接
一般刊物
- Thomale UW, Knitter T, Schaumann A, Ahmadi SA, Ziegler P, Schulz M, Miethke C. Smartphone-assisted guide for the placement of ventricular catheters. Childs Nerv Syst. 2013 Jan;29(1):131-9. doi: 10.1007/s00381-012-1943-1. Epub 2012 Oct 23.
- Thomale UW, Schaumann A, Stockhammer F, Giese H, Schuster D, Kastner S, Ahmadi AS, Polemikos M, Bock HC, Golz L, Lemcke J, Hermann E, Schuhmann MU, Beez T, Fritsch M, Orakcioglu B, Vajkoczy P, Rohde V, Bohner G. GAVCA Study: Randomized, Multicenter Trial to Evaluate the Quality of Ventricular Catheter Placement with a Mobile Health Assisted Guidance Technique. Neurosurgery. 2018 Aug 1;83(2):252-262. doi: 10.1093/neuros/nyx420.
- Schaumann A, Thomale UW. Guided Application of Ventricular Catheters (GAVCA)--multicentre study to compare the ventricular catheter position after use of a catheter guide versus freehand application: study protocol for a randomised trail. Trials. 2013 Dec 12;14:428. doi: 10.1186/1745-6215-14-428.
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- AAG-G-H1221
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Thomale-Guide的临床试验
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Kaohsiung Medical University Chung-Ho Memorial...National Health Research Institutes, Taiwan尚未招聘单颗牙缺失修复